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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81867

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 17, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Syntho Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01

D-0377-2019
Recall number
D-0377-2019
Initiated
April 17, 2017
Classification
Class II
Status
Terminated
Quantity
5,000 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

Code information

Lot #: S16E01, Exp 05/18

Distribution pattern

Product was sold to the firm's sole distributor who further distributed the product throughout the United States.

drug · product 2 of 2

EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01

D-0378-2019
Recall number
D-0378-2019
Initiated
April 17, 2017
Classification
Class II
Status
Terminated
Quantity
5,000 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

Code information

Lot #: S16E02, Exp 05/18

Distribution pattern

Product was sold to the firm's sole distributor who further distributed the product throughout the United States.